PG2 Injection 500 mg in Acute Stroke Study (Pass)

This study is currently recruiting participants.
Verified July 2013 by China Medical University Hospital
Sponsor:
Collaborators:
National Taiwan University Hospital
Shin Kong Wu Ho-Su Memorial Hospital
Tri-Service General Hospital
Changhua Christian Hospital
National Cheng-Kung University Hospital
Kaohsiung Medical University
En Chu Kong Hospital
Kuang Tien General Hospital
Chung Shan Medical University
Taipei Veterans General Hospital, Taiwan
Kaohsiung Veterans General Hospital.
Taipei Medical University Shuang Ho Hospital
Cheng Hsin Rehabilitation Medical Center
Taipei Medical University WanFang Hospital
Information provided by (Responsible Party):
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01603667
First received: May 20, 2012
Last updated: September 30, 2013
Last verified: July 2013
  Purpose

The primary objective of this study is to evaluate the efficacy of PG2 Injection 500 mg versus placebo, administered intravenously within 3-6 hrs of stroke onset to patients with an acute ischemic stroke, as determined by Modified Rankin Scale (mRS) score at Day 90.

The secondary objectives are as follows:

  • To evaluate the efficacy of PG2 Injection 500 mg versus placebo as determined by Barthel Index (BI) score at Day 90.
  • To evaluate the efficacy of PG2 Injection 500 mg in reducing the risk of recurrent stroke, cardiovascular events and death of all causes.
  • To evaluate the safety of PG2 Injection 500 mg treatment

Condition Intervention Phase
Acute Stroke
Drug: PG2
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PG2 Injection 500 mg in Acute Stroke Study (Pass): A Randomized, Double-Blind, Placebo-Controlled Study of PG2 Injection 500 mg in Patients With Treatment Started Within 3-6 Hrs of the Onset of Acute Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • The primary efficacy variable is the percentage of patients who are categorized as good functional outcome with mRS <2 [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients who achieve a Day 90 BI score of 95-100 Percentage of patients who are free of recurrent stroke, cardiovascular events and death of all causes. Percentage of patients who are free of adverse events [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: June 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PG2 Injection 500 mg
PG2 Injection 500 mg
Drug: PG2

STUDY DRUG DOSAGE:IV infusion of PG2 Injection 500 mg in 500 ml Normal Saline at a rate of 200 mg/hr with infusion started within 3-6 hrs of stroke onset and infusion of a total of 500 mg PG2 Injection in 500 ml Normal Saline or 500 ml Normal Saline will be completed within 2.5~3.5 hrs. The same dose of PG2 Injection 500 mg will be repeated daily for the subsequent 2 days.

ROUTE OF ADMINISTRATION:Continuous IV infusion via a calibrated infusion pump DURATION FOR EACH PATIENT:90 days

Other Name: Polysaccharides of Astragalus membranaceus
Placebo Comparator: Placebo
Placebo
Drug: placebo

STUDY DRUG DOSAGE: IV infusion of Placebo Injection 500 mg in 500 ml Normal Saline at a rate of 200 mg/hr with infusion started within 3-6 hrs of stroke onset and infusion of a total of 500 mg Placebo Injection in 500 ml Normal Saline or 500 ml Normal Saline will be completed within 2.5~3.5 hrs. The same dose of Placebo Injection 500 mg will be repeated daily for the subsequent 2 days.

ROUTE OF ADMINISTRATION:Continuous IV infusion via a calibrated infusion pump DURATION FOR EACH PATIENT:90 days

Other Name: placebo

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients presenting with acute ischaemic stroke
  2. Patient, or a family member with legally authorized responsibility, has given informed consent
  3. Age ≥20 years
  4. Infusion of study medication can be started within 3-6 hrs of stroke onset.
  5. NIHSS score of ≥ 7 - 24

Exclusion Criteria:

  1. Intracranial haemorrhage (ICH) identified by CT or MRI
  2. Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient having an NIHSS score of < 6 at randomization
  3. Pre-stroke mRS score of ≥ 2 (indicating previous disability)
  4. Known allergy to Astragalus membranaceus or its mayor derivatives (polysaccharides)
  5. Patients who are eligible for tPA treatment and has been treated with tPA.
  6. Participation in any investigational study in the previous 30 days
  7. Any terminal illness such that patient would not be expected to survive more than 1 year
  8. Any condition that could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study (this applies to patients with severe microangiopathy such as haemolytic uremic syndrome or thrombotic thrombocytopenic purpura). The judgment is left to the discretion of the Investigator
  9. Pregnant women (clinically evident)
  10. Previous stroke within last three months
  11. Past history or clinical presentation of ICH, arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm.
  12. Current use of oral anticoagulants with prolonged prothrombin time (INR > 1.6)
  13. Use of heparin, except for low dose subcutaneous heparin, in the previous 48 hrs and a prolonged activated partial thromboplastin time exceeding the upper limit of the local laboratory normal range
  14. Clinically significant hypoglycaemia (blood sugar < 50mg/dl)
  15. Uncontrolled hypertension defined by a blood pressure > 185 mmHg systolic or >110 mmHg diastolic on at least 2 separate occasions at least 10 minutes apart, or requiring aggressive treatment to reduce the blood pressure to within these limits. The definition of "aggressive treatment" is left to the discretion of the responsible Investigator
  16. Major surgery within the preceding 14 days which poses risk in the opinion of the Investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603667

Contacts
Contact: Chang-Ju Lin, Master +886-4-22052121 ext 7634 cjlin@cmuh.org.tw

Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Chang-Ju Lin, Master    +886-4-22052121 ext 7634    cjlin@mail.cmuh.org.tw   
Sponsors and Collaborators
China Medical University Hospital
National Taiwan University Hospital
Shin Kong Wu Ho-Su Memorial Hospital
Tri-Service General Hospital
Changhua Christian Hospital
National Cheng-Kung University Hospital
Kaohsiung Medical University
En Chu Kong Hospital
Kuang Tien General Hospital
Chung Shan Medical University
Taipei Veterans General Hospital, Taiwan
Kaohsiung Veterans General Hospital.
Taipei Medical University Shuang Ho Hospital
Cheng Hsin Rehabilitation Medical Center
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Chung Y. Hsu, PhD China Medical University Hospital
  More Information

No publications provided

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01603667     History of Changes
Other Study ID Numbers: DMR100-IRB-185
Study First Received: May 20, 2012
Last Updated: September 30, 2013
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 15, 2014